Caesarean Scar DefectTVARESNCT06599671
Effectiveness of Transvaginal Niche Resection Versus Expectant Management in Patients with Secondary Infertility and a Large Uterine Caesarean Scar Defect
A study testing Transvaginal niche resection in people with Caesarean Scar Defect, run by International Peace Maternity and Child Health Hospital.
Trial summary
The goal of this clinical trial is to evaluate the efficacy and safety of transvaginal niche resection in improving pregnancy outcomes of a large uterine caesarean scar defect (niche) with secondary infertility. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 19 to 48 years, women only
- Conditions the study is for
- Caesarean Scar Defect
- What is being tested?
- Transvaginal niche resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2024to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 48 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- It was diagnosed by MRI as a large niche (defined as niche with a depth of \>50% of the myometrial thickness and a residual myometrial thickness (RMT) ≤3mm);
- Infertility secondary to niche (the inability to conceive within 12 months of unprotected intercourse or repeated failed IVF);
- Fertility requirements;
- Signed informed consent.
Who cannot join
- Age below 18 years or over 49 years;
- Contraindications for intraspinal or general anaesthesia;
- A (suspected) malignancy or combined benign lesions requiring hysterectomy;
- Atypical endometrial cells or cervical dysplasia;
- Uterine or cervical polyps;
- Submucosal fibroids;
- Hydrosalpinx.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effectiveness of Transvaginal Niche Resection Versus Expectant Management in Patients with Secondary Infertility and a Large Uterine Caesarean Scar Defect (niche), a Randomised Controlled Trial
The goal of this clinical trial is to evaluate the efficacy and safety of transvaginal niche resection in improving pregnancy outcomes of a large uterine caesarean scar defect (niche) with secondary infertility. The main questions it aims to answer are:
- Does transvaginal niche resection improve pregnancy outcomes of a large uterine caesarean scar defect (niche) with secondary infertility?
- What medical problems do participants have when taking transvaginal niche resection?
Read more
Researchers will compare transvaginal niche resection to expectant management (without any additional surgical intervention) to see if transvaginal niche resection works to improve pregnancy outcomes of a large uterine caesarean scar defect (niche) with secondary infertility.
Participants will:
- Undergo a procedure (transvaginal niche resection) within 2 week after randomization in the intervention group. Women were advised to use contraception in the first 6 months following niche resection to allow uterine healing prior to subsequent pregnancy.
- Receive usual care at least 9 months which means no additional surgical intervention during this period in the control group. Patients are allowed to become pregnant and to receive fertility therapies if indicated. Any member of the control group who has not become pregnant after 9 months will be given the opportunity to undergo a transvaginal niche resection.
- Receive a standardized magnetic resonance imaging (MRI) evaluation of the niches. Niches will be evaluated at baseline in all groups and at 3 months after surgery.
- Be contacted by telephone at 6, 9 and 15 months to assess the primary and secondary outcomes.
- Conditions
- Caesarean Scar Defect
- Being tested
- Transvaginal niche resection
- Keywords
- caesarean scar defect
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transvaginal niche resectionProcedure or surgery
In short: the bladder was carefully dissected away from the uterus towards the abdominal cavity to open the vesicovaginal space and reach the peritoneum. The fingers on the anterior wall isthmus could touch the obvious scar-like defect. The weak scar tissue then thoroughly was removed.
| Study group | Role | What they receive |
|---|---|---|
| Transvaginal niche resection | Experimental | The patients assigned to the intervention group will undergo a procedure under general anaesthesia in lithotomy position. Receives: Procedure: Transvaginal niche resection |
| Standard of care | No intervention | The patients assigned to the control group will receive usual care at least 9 months which means no additional surgical intervention during this period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Live birth rate
Live birth is defined as a live born neonate beyond 24 weeks of gestation.
Measured: Total follow-up will extend to 15 months after randomization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Oct 2024 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caesarean Scar DefectStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Peace Maternity and Child Health Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06599671
- Sponsor's protocol ID
- IIT-2023-10
- Acronym
- TVARES
- Status last verified
- Sep 2024
- First submitted
- 13 Sep 2024
- Last updated
- 24 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Transvaginal Niche Resection Versus Expectant Management in Patients with Secondary Infertility and a Large Uterine Caesarean Scar Defect (niche), a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06599671
- Acronym / sponsor ID
- TVARES / IIT-2023-10
- Conditions
- Caesarean Scar Defect
- Keywords
- caesarean scar defect
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- International Peace Maternity and Child Health HospitalUniversity, hospital or other
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to evaluate the efficacy and safety of transvaginal niche resection in improving pregnancy outcomes of a large uterine caesarean scar defect (niche) with secondary infertility. The main questions it aims to answer are:
- Does transvaginal niche resection improve pregnancy outcomes of a large uterine caesarean scar defect (niche) with secondary infertility?
- What medical problems do participants have when taking transvaginal niche resection?
Researchers will compare transvaginal niche resection to expectant management (without any additional surgical intervention) to see if transvaginal niche resection works to improve pregnancy outcomes of a large uterine caesarean scar defect (niche) with secondary infertility.
Participants will:
- Undergo a procedure (transvaginal niche resection) within 2 week after randomization in the intervention group. Women were advised to use contraception in the first 6 months following niche resection to allow uterine healing prior to subsequent pregnancy.
- Receive usual care at least 9 months which means no additional surgical intervention during this period in the control group. Patients are allowed to become pregnant and to receive fertility therapies if indicated. Any member of the control group who has not become pregnant after 9 months will be given the opportunity to undergo a transvaginal niche resection.
- Receive a standardized magnetic resonance imaging (MRI) evaluation of the niches. Niches will be evaluated at baseline in all groups and at 3 months after surgery.
- Be contacted by telephone at 6, 9 and 15 months to assess the primary and secondary outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transvaginal niche resection | Experimental | Procedure: Transvaginal niche resectionThe patients assigned to the intervention group will undergo a procedure under general anaesthesia in lithotomy position. |
| Standard of care | No intervention | –The patients assigned to the control group will receive usual care at least 9 months which means no additional surgical intervention during this period. |
Who may qualify
- Ages
- 19 to 48 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- It was diagnosed by MRI as a large niche (defined as niche with a depth of \>50% of the myometrial thickness and a residual myometrial thickness (RMT) ≤3mm);
- Infertility secondary to niche (the inability to conceive within 12 months of unprotected intercourse or repeated failed IVF);
- Fertility requirements;
- Signed informed consent.
Key exclusion criteria (7 listed)
- Age below 18 years or over 49 years;
- Contraindications for intraspinal or general anaesthesia;
- A (suspected) malignancy or combined benign lesions requiring hysterectomy;
- Atypical endometrial cells or cervical dysplasia;
- Uterine or cervical polyps;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transvaginal niche resectionIn short: the bladder was carefully dissected away from the uterus towards the abdominal cavity to open the vesicovaginal space and reach the peritoneum. The fingers on the anterior wall isthmus could touch the obvious scar-like defect. The weak scar tissue then thoroughly was removed. | Procedure or surgery | Transvaginal niche resection |
Primary outcome
Live birth rate
Time frame: Total follow-up will extend to 15 months after randomization.
Live birth is defined as a live born neonate beyond 24 weeks of gestation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2024.
- Individual participant dataSharing planned: No
Related trials for Caesarean Scar Defect
Recruiting
Single- vs Double-Layer Cesarean Scar Repair and Myometrial Thickness
Caesarean Section, Cesarean Scar Closure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Transvaginal niche resection in people with Caesarean Scar Defect, run by International Peace Maternity and Child Health Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qunying Cai (086 13621906294, invain05@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Live birth rate (time frame: Total follow-up will extend to 15 months after randomization.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2024.